FDA 510(k) Application Details - K200509

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K200509
Device Name	System, Test, Vitamin D
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 102591 US Other 510(k) Applications for this Company
Contact	Paul DaSilva Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2020
Decision Date	05/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review